510(k) K153338 ยท HWC Screw, Fixation, Bone
Tiger Cannulated Screw System
| Applicant | Trilliant Surgical, Ltd., Houston TX, US |
| Decision | Substantially Equivalent, Jan 14, 2016 |
| Received | Nov 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for:
(1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and
(2) Combination Tiger/Tiger Headless Cannulated Terminated |
HWC | None listed |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for:
(1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and
(2) Combination Tiger Cannulated/T Terminated |
HWC | None listed |
| Jul 19, 2018 | Trilliant Surgical, LLC Instructions for Use and Surgical Cleaning and Sterilization Protocol for:
(1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and
(2) Trilliant Surgical Ltd Large Cann Terminated |
HWC | None listed |
| Jan 6, 2017 | Trilliant Surgical Ltd. Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O
The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.